As part of their collaboration, Paris-headquartered EUROAPI will develop and optimize innovative chemical synthesis routes and manufacture GMP batches for several second-generation cationic lipids as part of its CDMO activity. As such, EUROAPI will focus on lipids that are currently being tested as part of Phase I/II clinical trials that will support Sanofi’s mRNA vaccines platform, targeting indications including Flu.
The collaboration is based on a Master Agreement for the Development and GMP Manufacturing Services signed by the two companies in October last year.
“We are delighted to announce the expansion of our agreement with Sanofi for mRNA vaccines development as part of our CDMO activity," said Cécile Maupas, Chief CDMO Officer, EUROAPI.
"This collaboration is key for EUROAPI as it further evidences EUROAPI’s capabilities as well as confirms that the acceleration of CDMO activity is a strategic priority for the Group. We are extremely proud to continue being a partner of choice for Sanofi and look forward to working together in this promising project.”
Lipid nanoparticles in mRNA vaccines
Lipid nanoparticles play a crucial role in their ability to encapsulate, protect and transport mRNA to the cells . With capabilities across its Budapest and Frankfurt development and manufacturing sites (which includes large-scale chromatography purification equipment that complies with cGMPs) EUROAPI considers itself a global leader in the area.
“With 330 scientists, EUROAPI benefits from unique expertise in complex chemistry, analytics and regulatory, enabling it to find the right synthesis pathway in a swift manner and meet health authorities’ regulatory and quality requirements,” says the company.
EUROAPI is engaged in ten projectsto develop and/or manufacture new molecular entities in the Sanofi’s R&D portfolio.
Having established the dedicated CDMO business team in 2021, CDMO activity is a strategic priority for EUROAPI and is expected to reach around 35% of its total net sales by the end of 2025.
It points to promising results since since the establishment of the CDMO team: with 26 new projects won at the end of January 2022 spanning from 10 projects in pre-clinical/Phase 1, 6 projects in Phase 2, 4 projects in Phase 3 and 6 projects at commercial stage.